Arena, Eisai Win FDA Okay for Obesity Drug

Belviq is a serotonin 2C receptor activator.!--h2>

FDA approved Arena Pharmaceuticals and partner Eisai’s anti-obesity drug Belviq (lorcaserin hydrochloride) for chronic weight management in adults. Approval covers use of the drug as an adjunctive therapy combined with reduced-calorie diet and increased exercise in obese (BMI of 30 kg/m2 or greater) patients, or those who are overweight (BMI 27 kg/m2) and have a weight-related comorbid condition.

The drug will be manufactured by Arena, and marketed and distributed in the U.S. by Eisai. FDA has recommended Belviq to be classified as a scheduled drug, and the U.S. Drug Enforcement Administration is reviewing the recommendation prior to providing scheduling designation. A marketing authorization application for lorcaserin was accepted for filing by the EMA in March.

Eisai has exclusive rights to market and distribute Arena’s lead compound lorcaserin in the U.S., while Arena retains rights to lorcaserin in all other global markets. As part of the U.S. regulatory approval, Arena and Eisai will be required to carry out post-marketing studies evaluating the safety and efficacy of Belviq in obese pediatric patients, and to study the effects of long-term treatment using Belviq on cardiovascular events in overweight and obese subjects with cardiovascular disease or risk factors.

The Phase III trial program for Belviq comprised three placebo-controlled studies (Bloom, Blossom, and Bloom-DM) involving nearly 8,000 overweight or obese patients either with or without comorbid conditions including diabetes, hypertension, or dyslipidemia. The overall data showed that when compared with placebo, therapy using Belviq in combination with diet and exercise was more effective at helping patients lose 5% or more of their body weight after one year and managing weight loss for up to two years.

Arena’s early-stage clinical pipeline includes an oral prostacyclin receptor agonist APD811, which is undergoing Phase I trials for the potential treatment of pulmonary arterial hypertension. The firm has two preclinical candidates in active development. APD334 is an S1P1 receptor agonist in development as a potential oral therapy for autoimmune-related diseases including multiple sclerosis and rheumatoid arthritis. A non-psychotropic CB2-selective receptor agonist APD371 is in development as an analgesic.

Arena’s temanogrel is an inverse agonist of the serotonin 2A receptor, which has completed Phase Ia and Phase IIa studies as a potential treatment for arterial thrombosis and other related conditions, but is currently on hold due to the costs of later-stage trials. The firm says it isn’t currently planning further development of temanogrel, although it may consider restarting the program in the future either independently or through a partnership.

Meanwhile, research is ongoing to progress a series of orally available GPR119 agonists for the potential treatment of type 2 diabetes. The GPR119 program includes APD597 and next-generation compounds discovered after the research stage of Arena’s former collaboration with Ortho-McNeil-Janssen Pharmaceuticals. As part of the collaboration, which was terminated in 2010, Ortho-McNeil had progressed two Arena-discovered compounds APD668 and APD597 into clinical trials.